MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not yet been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the bending section of the subject device broke inside the patient with a non-olympus laser probe inserted into the channel of the subject device during rirs (retro intrarenal surgery) procedure.The subject device was withdrawn from the patient safely, but a part of the laser fell off into the patient.Therefore the user facility performed an open surgery in order to retrieve a part of the laser from the patient.The user facility also reported that the surgery was completed without complication and the condition of the patient is well.The subject device was delivered to the user according to an olympus field corrective action in 2018.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result and additional information from the user facility.The subject device and the piece of the laser fiber which fell off into the patient were returned to olympus (b)(4).A technical evaluation by olympus (b)(4) was carried out for the subject device.The primary evaluation report indicates the following; many image (ig) fibers were broken.Bending section was broken at 7 cm from the distal end.The rubber of the bending section was torn at the same location of the break.The angulation for the up direction didn¿t work at all, but the angulation for the down direction worked.A part of the bending tube at the proximate side was detached.Inside of the instrument channel was perforated at about 7 cm from the distal end.There was a scratch inside of the instrument channel at around 10 cm from the distal end.(b)(4) also conducted the evaluation of the piece of the laser, and confirmed following; the laser fiber was kinked at 3 locations.The length of the fiber was about 9 cm.The laser fiber kink was severely torn and had burn sign in the middle.The fiber was other kink points were also torn.Olympus representative visited the user facility to obtain additional information.The physician in charge of the procedure informed olympus about following; the bending section of the device had a little kink before the procedure.Inspection of the angulation and leakage test for the device was performed before the procedure.A 10 mm stone was located at lower-middle pole of the renal pelvis of the patient.The patient was suffered from hydronephrosis, therefore the patient's renal pelvis was enlarged, which was difficult to access the stone because there was no wall for the insertion tube of the subject device to contact.Due to the fact renal pelvis was enlarged, the device was pushed further to the kidney and the laser fiber had to be extended further from the distal end of the device.While the procedure, the laser was activated twice.After that, the physician noticed that lots of ig bundle was broken and up angulation didn't work.The device was withdrawn safely, but the piece of the laser fiber remained in the kidney.In order to retrieve the laser fiber from the kidney, another ureteroscope was inserted to the kidney via ureter, and it was tried to retrieve the laser fiber by an endotherapy device such as basket.But the laser fiber was stuck at kidney because the piece of the laser fiber was long.The physician commented that the kinks may be happened during the trail for laser fiber removal.Because it was not possible to retrieve the laser fiber by endoscopy, the classic open surgery was proceeded.The surgery went well and the patient health condition was fine.The stone haven't been removed from the kidney.The physician commented that another rirs procedure was planned to remove the stone.Considering the additional information, it was concluded with the user facility that due to the further push of the insertion tube to the kidney, the bending section and laser may be broke during the procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result for the subject device by olympus medical systems corp.(omsc) and additional information.The device was returned to omsc for evaluation.The evaluation by omsc confirmed the following; the bending section was broken at 7 cm from the distal end.There were perforations at 2 locations of the bending tube possibly caused by laser irradiation.The cable support of the bending tube in which angulation wire were guided does not detached.Many image (ig) fibers were broken.Furthermore, during reproductive experiment, under conditions as in this case of exaggerated space in renal pelvis by hydronephrosis, it was confirmed that the bending tube break at the proximate side by pushing the device into the exaggerated space excessively.Omsc consulted japanese physician regarding this case and the following opinion was obtained.Since physicians always observe the fluoroscopic image of the pelvis during ureteroscopic surgery, they can detect if there is an abnormal bending shape of the device.Since the surgery is performed while looking through the fluoroscopic image, if there is abnormality in the organ, physicians stop pushing the ureteroscope in consideration of the influence for the patient.Considering the result of evaluation and the consultation, it is surmised that inappropriate device handling by the user facility contributed to reported event.There are the following cautions in the instruction manual; check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.Do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7644574
• MDR Text Key: 112549465
• Report Number: 8010047-2018-01233
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other